JP2019500926A - Sensor set - Google Patents

Abstract

  An improved sensor set is provided for sensing physical properties such as glucose. The sensor set includes a mounting base portion for the sensor and a connector for connecting to the mounting base portion. The connector may contain sensor electronics for wired or wireless communication to an external monitor or display. The mounting base includes a connector fitting adapted to fit into a tubular recess in the connector, the connector fitting including a key. In some embodiments, the proximal end of the sensor is folded around the key such that there are contact pads on both sides of the key. The mounting base and connector include additional features such as pegs and prongs that allow the mating of the adaptive mounting base and connector while locking out non-conforming parts.

Description

(Technical field)
The present invention relates generally to connection configurations, and more particularly to connection configurations for use in sensor sets and insertion sets for monitoring bodily physical characteristics such as glucose. In particular, the present invention relates to a connector for a sensor set including a mounting base portion or a test plug having a connector, and the connector and the mounting base portion or the test plug are configured to be connected to each other.

(Cross-reference of related applications)
This PCT application was filed on Nov. 9, 2016, which is a continuation of U.S. Application No. 14 / 938,458, filed Nov. 11, 2015, and U.S. Application No. 14 / 938,458. US patent application No. 15 / 347,521 and US Provisional Patent Application No. 62 / 400,987, filed on Sep. 28, 2016, alleging the priority thereof.

(Description of related technology)
In recent years, a variety of electrochemical sensors have been developed for a wide range of applications, including medical applications for detecting and / or quantifying specific agents in patient blood and other body fluids. As one example, a glucose sensor has been developed for use in obtaining an index of blood glucose levels in diabetic patients. Such measurements may be particularly useful for monitoring and / or adjusting a treatment regimen that typically includes periodically administering insulin to the patient. In this regard, the blood glucose measurement value may be an external semi-automatic pharmaceutical infusion pump as generally described in Patent Documents 1 to 3, or an automatic implantable type as generally described in Patent Document 4. It is particularly useful in conjunction with a pharmaceutical infusion pump.

  Due to the subcutaneous placement of sensor electrodes in direct contact with the patient's blood or other extracellular fluids, relatively small and flexible electrochemical sensors have been developed, and such sensors have been developed for extended periods of time. It can be used to obtain periodic measurements. In one form, the flexible transcutaneous sensor is constructed according to a thin film mask approach, and the elongated sensor includes a thin film conductive element encapsulated between a flexible insulating layer of polyimide sheet or similar material. Such thin film sensors are typically external for convenient electrical connection between the electrode exposed at the distal end and a suitable monitoring device for subcutaneous placement in direct contact with the patient's blood or the like. And a conductive contact pad exposed at the proximal end located at Although such thin film sensors are significantly guaranteed in patient monitoring applications, unfortunately, it has been difficult to place sensor electrodes in direct contact with the patient's blood or other bodily fluids subcutaneously. Improved thin film sensors and associated insert sets are described in US Pat.

  U.S. Patent No. 6,057,056, which is hereby incorporated by reference, discloses coupling of a known insertion set. The application includes a mounting base for a foil sensor placed subcutaneously. The mounting base itself has a flat lower surface with a pressure sensitive adhesive that allows the mounting base to adhere to the surface of the patient's skin as an adhesive patch. The connection between the mounting base and the cable connector is provided by a cylindrical connector fitting that extends from the mounting base. This fits within the corresponding socket of the cable connector. An “O” ring around the base of the cylindrical connector fitting provides a seal. The end of the connector fitting is partially cut away to create a “D-shaped” cross-section, creating a flat surface parallel to the connector fitting axis. The head of the sensor foil contact bearing is supported on this flat surface. When the connector fitting is engaged with the socket, the spring contact in the socket touch contacts the contact pad of the sensor foil and is connected.

  Currently, there are sensor sets that include a mounting base for placement on a patient's skin that can be coupled to a connector having suitable sensor electronics (wired or wireless). Since the mounting base part may be sold separately, it is possible to mount non-conforming parts that may interfere with the sensor data. Furthermore, the number of contact pads and respective sensor electrodes is limited by the structure of the current sensor.

US Pat. No. 4,562,751 US Pat. No. 4,678,408 US Pat. No. 4,685,903 US Pat. No. 4,573,994 US Pat. No. 5,390,671 US Pat. No. 5,391,250 US Pat. No. 5,482,473 US Pat. No. 5,299,571 US Pat. No. 5,586,553 US Pat. No. 5,568,806 US Patent Application Publication No. 2008/0064944 US Pat. No. 7,660,615 US Pat. No. 7,602,310 US Pat. No. 5,851,197 US Pat. No. 6,093,172 US Pat. No. 6,293,925

  According to one embodiment of the first aspect of the invention, a sensor set for sensing patient characteristics is provided, the sensor set generating at least one electrical signal representative of patient characteristics such as blood glucose. A sensor having a distal segment at the distal end, the sensor including at least two contact pads at the proximal end, each of the at least two contact pads receiving an electrical signal from the distal segment. A sensor coupled to the distal segment and a mounting base operable to attach to the patient's skin, the mounting base being a connector fit at a generally rear end of the mounting base The connector fitting includes a tubular element having a central hole formed therein for pass through reception of a portion of the sensor. And a connector operable to couple to the mounting base portion, the connector including a tubular recess sized to receive a connector fitting of the mounting base portion, and the mounting base portion A connector fitting comprising: at least two connector contacts operable to be electrically coupled to at least two contact pads of the sensor when coupled to the connector; A key formed at one end, wherein the proximal end of the sensor has at least one of the at least two contact pads on the first side of the key and the other of at least one of the at least two contact pads. Is folded around the key so that it is on the second side of the key. The distal segment may include an electrode for measuring blood glucose that may be configured, for example, in a potentiostat. The connection between the distal segment and the contact pad may include electronics for supplying power to the sensor and / or processing signals. The sensor may be a foil having conductor tracks and electronic components manufactured according to known thin film technology.

  The test plug may be included as a part of the sensor set in addition to the mounting base portion. The test plug may be sold as part of the sensor set or as a separate body. It is also possible to sell sensor set parts such as a mounting base part or a connector without any other parts.

  At least two connector contacts of the connector are compression pins. The compression pin may be compressed into the first side of the key and the second side of the key when the mounting base is connected to the connector.

  It is also recalled that a test plug may be included, which is identical in structure to the above-described embodiment, but instead of being connected to the distal segment, the sensor is by a flexible circuit foil having a contact pad. Substituting and having a circuit for generating a test signal.

  The circuit foil of the sensor or test plug may include a short circuit path that becomes a shorted reference electrode and a counter electrode. Alternatively or additionally, the sensor or test plug circuit may include a resistor.

  The key shape may be substantially oval or rectangular. In an embodiment, the first side of the key is substantially flat. The second side of the key may also be substantially flat or may include a substantially flat end and a stepped portion. One or both sides of the key may include a seat or plane for receiving the proximal end of the sensor. In an embodiment, the key includes at least one protrusion adapted to fit into a protrusion recess formed in the mounting base. The first side of the key is substantially flat.

  The mounting base may include at least one arm generally adjacent to the tubular element of the connector fitting, wherein the at least one arm is formed in the connector when the connector is connected to the mounting base. It is formed to fit into two corresponding arm recesses.

  The connector fitting may include a first side rail formed on the first side of the connector fitting, and a second side rail formed on the second side of the side rail. When the connector is connected to the mounting base portion, the first side rail and the second side rail include a first slot formed in the tubular recess portion of the mounting base portion and a second slot formed in the tubular recess portion of the connector. Is operable to slide into the.

  The connector may include, for example, a sensor electrode that includes a wireless transmitter that is operable to transmit a signal from the mounting base. The at least two sensor electrodes may be operable to generate at least two electrical signals that are characteristic, and the at least two connector contacts are operable to receive at least two electrical signals. May be. These electrical signals may be transmitted via a wireless transmitter or may be transmitted by wire.

  The mounting base and connector may include a releasable interlocking snap-fit latch member that is operable to lock the mounting base to the connector.

  It may be easy to imagine the key as being an extension of the tubular element of the connector fitting, with the section or segment cut away. Thus, for example, in the case of a “D-shaped” cross-section key as shown in Patent Document 11, the notch is the lower half of the tubular element. This means that the key is useful for defining the final shape, rather than starting from the cylinder and actually being manufactured by removing the material.

  In accordance with a second aspect, a connector system is a cylindrical connector fitting having a connector foil having a contact pad at an end and a cylindrical element having a key formed at a distal end, the key comprising: A connector fitting, defined by a cut-out portion of the cylindrical element, to produce two flat surfaces each parallel to the axis of the cylindrical element, the flat surfaces facing away from each other A socket portion having a tubular recess sized to receive a cylindrical element and having a contact portion positioned to engage a contact pad of the connector foil, the socket portion comprising: A socket portion having a structure for occupying a space emptied by the cutout portion, and an end portion of the connector foil contacts a first flat surface of the flat surfaces. Head is mounted so as to be located opposite the first planar surface. The connector foil may be arranged such that it wraps around the end of the key so that it lies on both flat surfaces and the contact pad is opposite the flat surface. As an alternative to the foil wrapping the end of the key, the structure that can be located only on one side of the key and occupies the space emptied by the notch is a spring on one side of the key A contact and a protrusion inside the tubular recess on the other side of the key may be included. The first flat surface may be located on the diameter of the cylindrical element. Thus, on either side of the key there is either a contact or a protrusion that is part of the socket. This helps to stabilize the connector system and results in a more reliable connection.

  It is also recalled that the end of the key may have a predetermined profile and the inner end of the tubular recess may have a complementary interengagement profile. This can be useful to prevent engagement of non-conforming parts.

  Further stability may be provided by the use of the flat surface side walls of the key to protect the connector foil. Preferably, the side walls are at least as high as the thickness of the foil, so that the foil rests on a shallow mount on the flat surface of the key. In configurations where the first fold is present on the end of the key, the sidewall may be present only on the first surface.

  According to a further aspect, the present invention provides a sensor set for sensing patient characteristics, the sensor set comprising the connector system of the above aspect, wherein the connector foil includes a contact pad at the proximal end and a distal end. A medical sensor having a sensing structure at an end and an intermediate compartment, wherein the tubular element is formed as part of an attachment base operable to be attached to the patient's skin, and the pass-through reception of the intermediate compartment of the medical sensor With a central hole for. In an alternative configuration, a test plug including the above connector system is provided, and the connector foil includes a test circuit for testing a device coupled to the socket portion when the plug portion and the socket portion are engaged.

  In another aspect, a sensor set is provided for sensing patient characteristics, the sensor set having at least two sensor electrodes at the distal end for generating at least one electrical signal representative of the patient characteristics. A sensor comprising at least two contact pads at a proximal end, each of the at least two contact pads being conductively coupled to at least one of the at least two sensor electrodes; A mounting base adapted to be attached to a patient's skin and to connect the sensor to the sensor electronics, the mounting base including a connector fitting generally at the rear end of the mounting base; The fitting includes a mounting base that includes a cylindrical element having a central hole formed therein for receiving a pass-through of a portion of the sensor, and a mounting base. A connector adapted to connect to a base portion, wherein the connector is a cylindrical recess sized to receive a connector fitting of the mounting base portion and the mounting base portion is connected to the connector And at least two connector contacts adapted to be electrically coupled to at least two contact pads of the sensor, wherein the mounting base includes one or more latch arms. The connector includes one or more latch recesses, and the one or more latch arms are adapted to fit and lock into the one or more latch recesses when the mounting base is coupled to the connector. The mounting base portion further includes one or more anti-rotation arms, the connector includes one or more anti-rotation arm recesses, and the one or more anti-rotation arms include the mounting base portion. When coupled to connector, it is adapted to fit into one or more anti-rotation arm recess. The anti-rotation arm may be wider than its own height. The one or more latch recesses are the same as the one or more anti-rotation arm recesses, and the one or more latches fit into the same recess as the one or more anti-rotation arms.

  The mounting base may further include one or more lockout posts extending in the same direction as the one or more latch recesses, and when the mounting base is coupled to the connector, the connector is locked out. It includes one or more lockout pockets adapted to fit into the pillars.

  The test plug may be adapted to connect to the connector by a similar connection. For example, the test plug may include one or more test plug latch arms adapted to fit and lock into one or more latch recesses in the connector when the test plug is coupled to the connector. The plug may further include one or more test plug anti-rotation arms adapted to fit into one or more anti-rotation recesses of the connector when the test plug is coupled to the connector. The test plug may include one or more anti-rotation arm extensions between the central section of the test plug and the anti-rotation arm, the anti-rotation arm extension extending from the top of the central section. It is inclined to the part. The test plug also includes one or more test plugs that extend in the same direction as the one or more test plug latch recesses adapted to fit into a lockout pocket of the connector when the test plug is coupled to the connector. A lockout column may be included.

  The connector fitting may include a key formed at one end, the proximal end of the sensor having at least one of the at least two contact pads on the first side of the key, and the at least two contact pads. At least one of the other is folded around the key so that it is on the second side of the key. The key may include at least one prong adapted to mate with a prong recess formed in the mounting base. The first side of the key may be substantially flat. The first side of the key and the second side of the key each include a seat for receiving the proximal end of the sensor.

  The at least two connector contact portions of the connector may be compression type pins. The compression pin is compressed into the first side of the key and the second side of the key when the mounting base is coupled to the connector.

  The sensor may include a short circuit path that becomes a shorted reference electrode and a counter electrode. The sensor may include a resistor. The connector may include a wireless transmitter adapted to transmit a signal from the mounting base. It is recalled that the patient's characteristic is blood glucose. At least two sensor electrodes are adapted to generate at least two electrical signals that are characteristic, and at least two connector contacts are adapted to receive at least two electrical signals.

  In yet another aspect, a mounting base for a sensor includes a connector fitting at a generally rear end of the mounting base, the connector fitting formed therein for receiving a pass-through portion of the sensor. Wherein the sensor has at least two sensor electrodes at the distal end for generating at least one electrical signal representative of patient characteristics, the sensor having a proximal end At least two contact pads, each of the at least two contact pads being conductively coupled to at least one of the at least two sensor electrodes. The mounting base also includes one or more latch arms adapted to fit and lock into one or more latch recesses in the connector, the connector coupled to the mounting base and the sensor to sensor electronics. A cylindrical recess adapted to connect to the connector and sized to receive the connector fitting of the mounting base, and when the mounting base is coupled to the connector, at least two contact pads of the sensor are electrically connected At least two connector contacts adapted to be coupled together. The mounting base portion also includes one or more anti-rotation arms adapted to fit into one or more anti-rotation recesses of the connector when the mounting base portion is coupled to the connector. The anti-rotation arm may be wider than its own height.

  Reference is now made to the following figures for a more complete understanding of the present disclosure. In the drawings, like reference numerals refer to like items throughout the drawings.

It is a perspective view of a connector and a mounting base part. It is a perspective view of a connector and a test plug. It is an enlarged view of the connector which has a wireless sensor electronic device. It is a perspective view of the sensor set which has an insertion tool. It is an enlarged view of a mounting base part including a sensor and an insertion tool. It is an expansion perspective view which shows the assembly of the components of the mounting | wearing base part containing a sensor. It is a lower side enlarged view of the mounting base part containing a sensor shown in FIG. It is a lower side figure of the mounting | wearing base part shown in FIG. It is another enlarged view of the mounting | wearing base part which has a holding | maintenance cap. It is another enlarged view of the mounting | wearing base part which has a holding | maintenance cap. FIG. 11 is a lower view of the holding cap shown in FIG. 10. It is a perspective view of the mounting base part which has a holding cap. It is a perspective view of the insertion needle installed in the assembled mounting base and the holding cap. FIG. 14 is a cross-sectional view generally taken along line 11 to 11 in FIG. 13. It is a front perspective view of the connector in the form of a cable connector. It is a disassembled perspective view of the connector of the form of a cable connector. It is a perspective view which shows removing an insertion needle from a sensor set after arrange | positioning a mounting base part on a patient's skin. It is a perspective view which shows the sensor set and cable connector with which the patient's skin was mounted | worn after removing an insertion needle. It is a top view of a test plug. It is a side view of a test plug. It is a perspective view of a test plug. It is a fragmentary perspective view of a connector. It is a perspective view of a test plug. It is a partial perspective view of a mounting base part or a test plug. It is sectional drawing in alignment with the socket fitting tool of a mounting base part. It is sectional drawing in alignment with the socket fitting tool of a mounting base part. It is sectional drawing in alignment with the socket fitting tool of a mounting base part. It is an expansion perspective view of the pin used as a contact part in a mounting base part. It is an expansion perspective view of the pin used as a contact part in a mounting base part. It is a notch figure of the connector connected with the test plug. It is a perspective view of the mockup which shows the connection between a connector and a test plug or a mounting | wearing base part. FIG. 6 is a cutaway view of various lockout connections between a test plug or mounting base and a connector. FIG. 6 is a cutaway view of various lockout connections between a test plug or mounting base and a connector. FIG. 6 is a cutaway view of various lockout connections between a test plug or mounting base and a connector. FIG. 6 is a cutaway view of various lockout connections between a test plug or mounting base and a connector. FIG. 6 is a cutaway view of various lockout connections between a test plug or mounting base and a connector. FIG. 6 is a cutaway view of various lockout connections between a test plug or mounting base and a connector. FIG. 3 is a diagram of a contact pad for a sensor. It is a perspective view of a mounting base part. It is a perspective view of a mounting base part. It is a side view of a mounting base part. It is a fragmentary perspective view of a connector. It is a partial proximity side view of a connector. It is a perspective view of a mounting base part. It is a fragmentary perspective view of a connector. It is a perspective view of a test plug. It is a perspective view of a test plug. It is an internal part notch figure of the mounting base part which has a sensor.

  The following description and drawings illustrate embodiments that are sufficiently specific to enable those skilled in the art to practice the systems and methods described. Other embodiments may incorporate structural and logical processes and other changes. The examples simply show possible modifications. Unless specifically required, individual elements and functions are generally optional and the sequence of operations may vary. Parts and features of some embodiments may be included in, or substituted for, other parts and features. In particular, any structure described with respect to the connection between the test plug and the connector also applies to the connection between the corresponding mounting base and the connector.

  As shown in the exemplary drawings, an improved sensor set is provided for monitoring physical characteristics of the body. An improved structure of the connection between the various parts of the sensor set is also provided. One exemplary physical characteristic is the body's blood glucose level. As shown in FIG. 1, the embodiment of the sensor set includes a sensor mounting base portion 30 and a connector 20. The connector 20 shown in FIG. 1 includes wireless sensor electronics having a sensor transmitter (not shown) in the housing.

  Further details of the connector 20 are given below in the discussion of FIG. The mounting base portion 30 shown in FIG. 1 functions as a mounting portion for the foil of the thin film sensor, as best shown in FIGS. 6 and 7 below. The mounting base portion 30 has a flat lower surface optionally provided with a pressure sensitive adhesive (not shown) that allows the mounting base portion 30 to adhere to the surface of the patient's skin as an adhesive patch. Consists of. One edge of the mounting base 30 includes a cylindrical connector fitting 36 having a cylindrical or tubular element 42 having a shaft hole 44. The cylindrical or tubular element 42 has a notched tip that defines a key 50 that includes a flat surface parallel to the axis. The contact pad 18 exposed at the proximal end of the sensor is supported by this flat surface. The sensor foil intermediate section passes the foil through the bore 44 of the cylindrical or tubular element and exits the foil through the underside of the mounting base so that the contact pad 18 is under the patient's skin. Connected to the sensing element. In order to sense the glucose concentration, the sensing element may typically be a potentiostat electrode 15. The connection between the contact pad and the sensing element optionally includes processing circuitry.

  The sensor mounting base portion 30 is connected to the connector 20 by a cylindrical connector fitting tool 36. The connector 20 includes a socket 92 sized for sliding engagement with the connector fitting 36 of the mounting base. The cylindrical or tubular element 42 optionally comprises a pair of spaced apart “O” rings 48 mounted in an external groove 46 in the surface to seal against a corresponding surface inside the socket 92; Form a moisture-proof connection. On both sides of the connector fitting 36, the mounting base 30 has an elastic latch arm 97 and a latch tip 98 that can be fitted into the latch recess 100 of the connector 20 and held in the latch recess 100. When the mounting base portion 30 is connected to the connector 20, the latch front end portion 98 is engaged with the latch recess 100. These are released by pushing the latch arm 97, and the connector 20 can be removed from the mounting base. A narrow, generally oval or rectangular mating key 50 is formed as a rearward extension of a cylindrical or tubular element adapted to slide into a socket fitting 92 of connector 20.

  As described above, the distal end of the connector fitting 36 extending from the cylindrical or tubular element 42 includes a key 50. The key 50 is essentially cylindrical and either either side is parallel or the end is slightly tapered. The outer section of this end shape is removed, leaving two or more flat surfaces parallel to the axis of the tubular element. In the configuration shown in FIG. 1, the key 50 has its entire lower half removed to form a downward “D-shaped” cross section. The upper pair of “D” sections are removed to produce a pair of flat surfaces separated by a central ridge. This structure is shown in more detail in FIG. The pair of flat surfaces face away from the "D" shaped straight flat surface. Due to the correspondingly shaped structure in the socket 92 of the connector 20, the connector fitting is supported from two parallel sides, thereby improving stability. In the configuration of FIG. 1, the connection pads on the foil of the thin film sensor (not shown) supported by the mounting base are placed against the surface formed on the straight side of the “D” cross section. These connection pads engage with spring contacts inside the socket 92 of the connector 20. The pair of flat surfaces are oriented in the other direction and have no contacts, but still engage the corresponding protrusion surfaces of the socket 92 of the connector 20.

  The connector 20 can also be used with a test plug 130, one embodiment of which is shown in FIG. Such a test plug 130 may have the same overall configuration as the mounting base portion 30 shown in FIG. 1 in terms of the connector fitting 36 for connection with the connector 20. However, the configuration of FIG. 2 represents an important alternative configuration for the connector fitting 36. Such connector fitting 36 may also be used for the mounting base portion of FIG. In the configuration of FIG. 2 and removal of the lower half of the key 50 that forms a flat surface parallel to the axis of the tubular element 42, a flat surface is formed by removing a section from the shape of the top surface of the key 50. As a result, the key 50 has a trapezoidal shape having a side with a round cross section. This configuration is also shown in FIGS. 19-23 and will be described in more detail below. When the connector fitting 36 of FIG. 2 is provided, a pair of flat surfaces facing opposite directions ensure that the test plug of FIG. 2 or the mounting base of FIG. 1 is supported from both sides within the connector 20. Make it possible. This configuration also allows the connector foil to wrap around the end of the key, allowing connection to a foil having a larger number of contacts. This results in one set of contacts on the lower surface and another set of contacts on the upper surface. In this case, stability and concentration can be provided via the contact in the connector 20. When attached to the sensor connector 20, the test plug shown in FIG. 2 is provided with a strong seal by the “O” sealing ring 48, so that the patient can intrude water into the socket 92. These parts can be cleaned without any problems. This is useful in embodiments having a wireless transmitter, particularly in embodiments that are sealed within the connector 20. Test plug 130 also allows testing of wireless transmitters or other sensor electronics in connector 20 without receiving data from any sensors. Thus, the sensor electronics can be tested alone and without external sensor noise. Like the mounting base 30, the test plug 130 includes a key 50 that is adapted to slide into the socket fitting 92 of the connector 20. The test plug 130 also includes a latch arm 97 and a latch tip 98 that can interact with the latch recess 100 on the connector 20. When the test plug 130 is coupled to the connector 20, the latch tip 98 is locked in the latch recess 100. These are released by pushing the latch arm 97 and the connector 20 can be removed. In practice, a sensor kit as commercially available may include a connector, a mounting base, and a test plug, the connector being physically connectable to both the test plug and the mounting base, It is configured to be electrically compatible.

  For the sake of unification, we continue to refer herein to the “tubular element” 42 which forms part of the connector fitting 36 in both the mounting base and the test plug case. However, it is recalled that the tubular element is solid (that is, without a hole through it). This may be the case when all of the circuitry for the test plug is attached to the contact foil, or in the case of a sensor, the connection to the distal end need not pass through the element.

  Test plug 130 also allows testing of wireless transmitters or other sensor electronics in connector 20 without receiving data from any sensor. Thus, the sensor electronics can be tested alone and without external sensor noise. For example, the test plug may be a simple tester that produces a single flow such as 53.5 +/− 10% that can be detected by the sensor electronics and read by the monitor device. In some embodiments, the tester shorts the reference electrode and counter electrode described herein.

  An exemplary connector 20 that includes sensor electronics with a wireless transmitter is shown in FIG. The housing consists of an upper shell housing part 201 and a lower shell housing part 207. The housing includes a circuit board 202 and an antenna 203. The circuit board may include an application specific integrated circuit (ASIC). Although one preferred antenna shape is shown in FIG. 3, other configurations are contemplated that would allow a suitable antenna to be fitted into the connector. When the sensor mounting base portion 30 is connected to the connector 20, the sensor electronic device on the circuit board 202 can receive a signal from the sensor housed in the mounting base portion 30, and the mounting base portion 30 is connected to the connector fitting 36. The contact plug / pin housing 206 holds the molded pin 205 and forms the interior of the socket 92 so that the profile of the key 50 ensures that it is securely held in contact with the connector 20. It is installed inside 201/207. Sensor electronics including wireless transmitters are discussed, for example, in US Pat.

  As an alternative to the configuration described with respect to FIGS. 1 and 2, the connector may include a cable termination wired directly to a monitor that may or may not include a display. Depending on the needs of the user, it may include only a wire connector, or it may include a plurality of sensor electronics including a wire connector.

  The connector 20 may include a rechargeable power source such as a rechargeable battery. The rechargeable power source may be charged using a charger that holds the connector or is otherwise coupled to the connector to recharge the power source. An exemplary charger is shown, for example, in US patent application Ser. No. 12 / 434,076 filed May 1, 2009, which is incorporated herein by reference.

  The sensor set and any associated monitor may be of a type suitable for determining the glucose level in the user's body and / or body fluid, and are hereby incorporated by reference. Can be used in conjunction with an external or implantable automatic or semi-automated pharmaceutical infusion pump for delivering insulin to a diabetic patient, as described in. However, the present invention may be used in configurations that determine the level of other agents, properties, or compositions such as hormones, cholesterol, medication concentration, pH, oxygen saturation, viral load (eg, HV). You will understand that. The sensor set may also include functionality that is programmed or calibrated using data received by the sensor electronics, or the sensor set may be calibrated at the monitoring device. The sensor system is mainly adapted for use in human subcutaneous tissue. However, the sensor system may be placed in other types of tissues such as muscle, lymph, organ tissue, veins, arteries and may be used for animal tissue. It should be understood that the term “patient” can be broadly interpreted to encompass humans and other animals, and the term “blood” includes patient blood and other patient extracellular fluids. Embodiments can provide sensor readings intermittently or continuously.

  The sensor set primarily discussed herein uses electrode type sensors. However, the system may use other types of sensors such as chemical and optical systems. The sensor may be of the type used on the outer surface of the skin or it may be of the type placed under the user's skin layer. Some surface-mounted sensors may be able to use tissue fluid collected from under the skin.

  When the connector has sensor electronics including a wireless transmitter, the sensor electronics generally has the function of transmitting data. However, in alternative embodiments, these sensor electronics may include a receiver, or the transmitter may be a transceiver having a function of receiving data. 4-18 illustrate a direct connection to a wire that can carry signals to a separate sensor electronics that can include a monitor or display and can also (or alternatively) transmit data to an external monitor or display.

  As shown in FIGS. 6-8, the flexible thin sensor 12 foil is an elongated conductive element 24 (see FIG. 5) embedded or encapsulated between layers of a selected insulating sheet material such as a polyimide film or sheet. 6) to include relatively thin elongated elements that can be constructed according to the so-called thin mask technique. In some embodiments, the flexible thin sensor may be contained in a flexible tube to provide support. However, thicker sensors can be sufficiently stiff to facilitate assembly to the base of the sensor and reduce the number of sensor kinks without a flexible tube. A thickness of about 17-40 micrometers, for example 25 micrometers, is thick enough to provide this stability. The proximal end or head 16 of the sensor 12 is relatively enlarged and conductive contact exposed through the insulating sheet material for electrical connection to the cable 22, as will be described in more detail. A pad 18 is defined. The opposite or distal segment of sensor 12 includes a plurality of corresponding exposed sensor electrodes 15 for contacting the patient's bodily fluid when the sensor's distal segment is positioned within the patient's body. The sensor electrodes 15 generate electrical signals that are representative of the patient's condition, but these signals are via contact pads 18 and connectors that may include sensor electronics (wired or wireless) or simple wire connection. Sent to a suitable monitoring device (not shown) for recording and / or a display that monitors the patient's condition. A further description of this general type of flexible thin sensor can be found in US Pat. A further description of wired sensor electronics can be found in US Pat.

  In addition to the methods shown in the patents incorporated herein by reference, a no-pre-plating wet etching process or pulse + DC plating that allows for a uniform platinum morphology Sensors can be made by the (pulsed + DC plating) process. In the enzyme encapsulation method, glucose oxidation (GOx) enzyme is encapsulated in a photosensitive polymer that crosslinks upon UV exposure. Using this type of photosensitive polymer eliminates the need for a glutaraldehyde crosslinking step and the selective curing of the photosensitive polymer provides the ability to have the enzyme only across the sensing working electrode.

  The sensor 12 is carried by the sensor set, but specifically on a mounting base 30 adapted to be placed against the patient's skin (FIGS. 17 and 18) at a selected insertion location. Be transported. The sensor set generally has a generally planar or flat lower surface 32 (FIGS. 7 and 8) attached to an adhesive patch 34 for a press-on adhesive that is attached to the patient's skin. A compact mounting base 30 is included. The patch is not too large for comfort or is not too large to be easily attached to the patient, but can be sized to have as much adhesion as possible to the skin. The adhesive patch may be made of a stretchable material that increases comfort and reduces failure due to thinness. It should be understood that alternative methods of attaching the mounting base to the patient's skin other than adhesive patches can also be envisaged. The mounting base 30 is generally manufactured from light plastic so that it can be comfortably worn over numerous activities by the patient. The mounting base 30 includes a connector fitting 36 for sliding connection with the sensor connector 20, which may include only a cable for connection to a wireless transmitter, wired electronics, or external sensor electronics and / or monitor. Including, it may be manufactured as a single molding of light plastic. A hole 44 through the connector fitting 36 leads to an upwardly opening concave groove or channel 38 formed in the top surface 40 of the mounting base 30 (eg, FIG. 6), and thus the proximal or head 16 and distal ends. And receive and support the sensor 12 between them.

  5-8 illustrate the mounting base 30 including a rearwardly protruding tubular element 42 that defines a central bore 44 that is generally coaxially aligned with the rearward end of the recessed channel 38. Tubular element 42 includes an outer groove 46 (FIG. 5) for receiving a sealing ring 48 adapted for sealed sliding engagement with cable connector 20, as will be described. The rearward end of the tubular element 42 terminates in a key 50 formed as a rearward extension that includes a “D-shaped” cross-section with a pair of flat surfaces with a curved back apex. Thus, the key has a flat surface that extends parallel to the axis of the tubular elements on both sides and faces away from each other. When engaged with the connector, the flat surface, including the straight side of the “D”, supports the contact pad 18 against the spring contacts in the connector, while corresponding to the material removed from the apex of the “D”. The pair of flat surfaces engages the structure in the connector, providing stability and reaction force.

  19 to 23 show a connection configuration relating to the test plug and the connector. However, the same arrangement can be considered for the corresponding mounting base portion. In the following description, modifications of both the mounting base portion and the test plug will be considered. In the case of the mounting base part, the contact part means the contact part of the proximal end of the sensor that is directly connected to the electrode or connected to the electrode through a circuit attached to the electrode. In the case of a test plug, the electrode is an electrode of a test circuit. Referring to FIG. 28, as will be apparent from the following description, the configuration or layout of the contact portion of the test plug and the actual sensor is the same.

  As shown in FIGS. 19-21, the upper and lower portions of the key 50 are each substantially flat and incorporate shallow planes or seats 152 and 153, respectively. The concave seat is sized and shaped to receive and support the flexible test circuit, and in the case of a mounting base as shown in FIG. Extending from the head 16 and sized and shaped to receive and support the proximal head 16 of the sensor 12 present in the recessed channel 38. A concave seat that allows the underside of the key to change from a narrow depth to a slightly wider depth can include a shelf 154 (FIG. 20). This shelf allows a unique fit of the current key only to the mating connection piece of the sensor connector, including the matching recess. The shelf further improves connection durability and robustness. As can be seen in FIG. 21, the proximal head 16 of the sensor 12 or of the flexible test circuit is configured to be folded around the key 50 so that the contacts are present in both seats 152 and 153. May be. In an embodiment of this configuration, the sensor's flexibility test circuit or proximal head 16 may include two sets of contact pads 18. For example, in FIG. 28, one embodiment of a contact pad diagram is shown. Of the illustrated contact pads, two are for the reference electrodes (180, 181), two are for the counter electrodes (184, 185), and one is for the two working electrodes (182, 183). For each.

  The short circuit path 186 allows for shorting of the reference / counter electrode, and the resistor (s) can be used to configure additional working electrode (s) and counter electrode (s). By allowing additional contact pads to be added to the same space, additional electrodes can be used in the sensor without the need for additional sizes of mounting bases or connectors. In the configuration shown in FIG. 28, the folds in the substrate 180 generally follow the straight lines 1800-1800 so that one set of contact pads exists on both sides of the key 50. In alternative embodiments, it is contemplated that a single set of contacts can be included on only one side of the key 50, as shown in other embodiments herein.

  As shown in FIG. 23, the key 50 may include prongs 501 and 502 that fit into respective prong recesses in a connector (not shown) and lock out other incompatible connectors. The prongs also assist in the rotational stability of the connection and help ensure a good connection between the connector and the mounting base. Each prong recess in the connector is shown in FIG. 31 (partial view of the connector).

  In an alternative embodiment shown by way of example in FIG. 8, the rear end of the tubular element 42 has a generally D-shaped or semi-circular mating key 50 with a pair of cutouts in the top formed as a rearward extension of the tubular element. The key 50 incorporates a shallow concave plane or seat 52 formed at the rear end of the hole 44. The concave seat 52 receives and supports the proximal head 16 of the sensor 12.

  In a further embodiment, the rear end of the tubular element 42 terminates with a generally D-shaped or semi-circular mating key 50 that is cut out at the top to form a rail 503 (as shown in FIG. 24). This rail 503 corresponds to the trench 125 (as shown in FIG. 25B) of the mounting base. The rail provides additional stability and prevents other non-conforming parts that do not include a rail / trench configuration from interfacing with a part having a rail / trench configuration.

  In an embodiment, the head 16 of the sensor 12 is fixed or placed in the recessed seats 52, 152, 153, such as by suitable adhesive. Further, after placing the sensor 12 through the hole 44, the hole 44 may be sealed and sealed with a suitable sealant, such as a curable silicone sealant.

  In order to facilitate sliding engagement with the sensor connector 20, the seat 52 may be formed to be inclined at an angle rearward and upward from the central axis of the hole 44, thereby downwardly. In addition, the sensor head 16 can be supported by the contact pad 18 provided at an angle and rearwardly.

  Since both configurations of the key described above can be present in various mounting bases that differ in compatibility, the key allows one configuration of the mounting base 30 to be used with other configurations of the connector 20. It functions further to prevent. Thus, the key allows for compatibility with the sensor connector and associated monitor, and prevents chemical or technical incompatible parts from being used with each other.

  Thus, in an embodiment, the recessed channel 38 of the mounting base 30 receives and supports the proximal segment of the thin sensor 12. As shown in FIGS. 6, 9, and 10, the recessed channel 38 extends forward from the mating hole 44 while maintaining a generally horizontal orientation and then downward and forward at an angle of approximately 45 degrees. It bends and extends along an angled surface 53 in a gap 54 that opens forwardly formed in the front end or nose of the mounting base. In some embodiments, the cannula 58 is slidably fitted over at least a portion of the proximal segment of the sensor 12 and extends over the distal segment to encase and protect the sensor. doing. In a preferred form, the cannula is made from a lightweight plastic material, such as urethane-based plastic, and has a double lumen configuration. The double lumen cannula 58 is particularly suitable for sliding engagement and disengagement to the insertion needle 14, as will be described in more detail, and includes a window 59 for exposing the sensor electrode 15. A specific cannula structure for receiving and supporting the sensor 12 and slidably internally mating with the insertion needle 14 is shown and described in more detail in US Pat. Has been.

  In a further embodiment, the insertion method is included as part of the sensor set. For example, the sensor cap can be inserted by the holding cap 60. In an embodiment, the proximal end of the sensor 12 and a portion of the sensor cannula 58 are folded as shown in FIG. 10 to follow the contour of the channel 38 of the mounting base, and the distal segment of the sensor and the sensor The cannula extends and projects downward and forward from the front of the mounting base 30. The sensor and cannula can be captured and held in this orientation by the holding cap 60 shown in FIGS. The retaining cap 60 may also be conveniently and economically formed as a lightweight plastic molding and includes means for quick and easy snap-fit attachment to the mounting base 30. When the retaining cap 60 is assembled to the mounting base 30, these parts cooperatively close the top of the channel 38 to capture and retain the sensor and internal cannula. The retention cap 60 further defines a needle port 78 (FIGS. 12 and 13) for receiving a pass-through of the insertion needle 14. The insertion needle 14 has a hollow, longitudinally slotted feature (FIG. 14) that has a pointed or sharp tip and rear end that is secured to the flared hub 80. The hub 80 is manually operated to slide the slotted needle and engage the cannula 58 within the forward and downward angled portions of the cannula 58 to move the needle 14 through the cap port 78. Fit. In this regard, the needle port 78 orients the insertion needle 14 relative to the proper angle and rotational alignment relative to the cannula 58 to ensure proper sliding engagement between the needle port 78 and the insertion needle 14. The size and shape are determined as follows.

  More particularly, the hub 80 includes an enlarged tab-like wing 82 adapted for easy gripping and handling between the thumb and index finger. The enlarged wings 82 protrude upwardly from a branch nose 84 that is sized and shaped to be placed on the top surface 40 of the mounting base on either side of the raised central section 86 of the retaining cap 60. The hub nose 84 is contoured along a defined adjustment alignment surface or guide surface 88 to engage and contact an associated adjustment alignment surface on the mounting base 30. The alignment surface is defined by the upper surface 40 of the support bracket 68 and the front surface 90 presented at an angle of the support bracket 68. This configuration allows the hub 80 to extend through the cap port 78 with the correct angle and rotational direction for sliding engagement and disengagement with respect to the cannula 58. The base plate 30 is slidably displaced with respect to the mounting base portion 30. In a preferred form, the insertion needle 14 is slidably assembled to the cannula 58 and protrudes from the mounting base, as described in US Pat. (FIG. 14) is provided.

  15 and 16 show a connector 20 for coupling with the assembled insertion set 10. A cable connector is used for a wired connection to a monitor or display. Alternatively, the connection component of the cable connector may be on a connector that includes sensor electronics that can be wired or wirelessly transmitted to a monitor or display. As shown, the cable connector 20 includes a compact coupling element that can also be manufactured from lightweight molded plastic. The cable connector 20 defines a socket fitting 92 for mating so as to slidably engage the cable fitting 36 at the rear of the mounting base portion 30. The socket fitting 92 has a cylindrical inlet portion 93 that merges with a generally D-shaped or semi-circular stepped portion 94 sized to receive the D-shaped key 50 of the fitting 36. The flat bottom insert provided at the top of the cylindrical socket provides a reaction to the plane at the top of the “D-shaped” cross section of FIGS. As shown, the socket fitting 92 is configured such that when the insertion set 30 or test plug 130 and the cable connector 20 are coupled together, the contact pad 18 of the sensor 12 for the mounting base embodiment, Or, in the case of a test plug embodiment, includes a plurality of conductive contacts 96 (FIG. 15) positioned in the stepped portion 94 for electrically coupled engagement with the contact pads 18 of the test circuit. Referring to FIG. 16, when assembled, the sealing ring 48 seals and engages the inlet portion 93 of the socket fitting 92 to provide a sealed connection between the parts. The shape of the internal mating parts 50 and 94 ensures a unidirectional internal connection for the correct conductive connection of the cable 22 of the sensor 12.

  More advanced insertion tools may be used to insert the sensor into the patient. Insertion tools that can interact with the mounting base of the present invention are shown, for example, in US Pat. In an embodiment, as shown in FIG. 37, the mounting base portion includes one or more inset cutouts 77 for interacting with the insertion tool, making the interaction for an insertion tool more specific. The inset notch 77 can also allow better stability during insertion.

  In a further embodiment, a shim may be attached to the mounting base 30 as shown in FIG. 38 (partially cutaway view). The shim 17 is attached as part of the sensor 12 to prevent it from being pulled out. This minimizes friction between the sensor and the needle during insertion, eliminates the margin for movement in the cavity of the mounting base, and the rigidity of the sensor along the vulnerable neck-down region of the mounting base Is improved.

  Several embodiments of conductive contact 96 are shown in FIGS. 25A-25F. While a certain number of conductive contacts are shown in these figures and a corresponding number of sensor contact pads are shown in other figures herein, enough to be able to determine data related to sensed body characteristics It is envisioned that different numbers of conductive contacts and corresponding sensor contact pads can be used as long as the number is large. 25A-25C show cutaway views of a socket fitting 92 having an electrically conductive contact 96 therein. FIG. 25A has two planes at the top (FIGS. 4-18), and when the key fits into the socket fitting 92, the conductive contact 96 becomes generally a pin that touches the contact pad of the key 50. The fitting tool of the character-shaped part 94 is shown. FIG. 25B shows another embodiment in which the D-shape is slightly cut out and a rail that fits the runner 125 is added. The runner 125 not only can prevent non-conforming parts from being used with this sensor connector, but also provides additional stability such as rotational stability. FIG. 25C shows an embodiment in which there are two sets of pins 96 that will contact the conductive contacts because the conductive contacts are on both sides of the key. Further views of the conductive pins are shown in FIG. 25D (pins from FIGS. 25A and 25B) and FIG. 25E (pins from FIG. 25C shown in enlarged form). FIG. 25F shows an embodiment where the test plug 130 fits into the connector 20. Due to the pin configuration, the pin is compressed to some extent when the key is inserted into the socket. Unlike the situation with two inflexible contacts that require precise moldings to contact each other, this compression ensures that the contact pad contacts the pin each time. In addition, these pins provide additional stability while they are pressed into the contact pad of the key 50.

  The mounting base portion 30 and the cable connector 20 are held in a releasable connection relationship by a snap-fit latch member engaged with each other. For example, as shown in FIGS. 15 and 16, the mounting base portion 30 is formed to include a pair of rearward protruding cantilever type latch arms 97 that terminate at the rear ends of the respective undercut latch tip portions 98. . The latch arm 97 is sufficiently and naturally resilient to movement relative to the rest of the mounting base 30 so that the latch arms are clamped inward toward each other. The allowable movable range allows the latch tip 98 to snap-engage with the corresponding pair of latch recesses 100 formed in the cable connector 20 on both sides of the socket fitting 92, Along with the latch keeper 102 for engaging the latch tip 98. The mounting base 30 is axially separated from the cable connector 20 while, if desired, engaged to disengage the parts by manually squeezing the latch arms 97 inward toward each other to release from the latch keeper 102. Can be canceled.

  Further, as shown in FIGS. 19 and 34, the test plug 130 (not shown in FIG. 34) or the mounting base 30 (not shown in FIG. 19) includes anti-rotation arms 115 and 116. In one embodiment, as shown in FIG. 19, the anti-rotation arm is generally adjacent to the tubular element 42 that includes the key 50. Connector 20 (partially shown in FIG. 22) includes anti-rotation arm recesses 215 and 216 that correspond and fit with the anti-rotation arm. In the embodiment shown in FIG. 22, the connector also captures recesses 217 and 218 that can capture the anti-rotation arm when the anti-rotation arm has a hook, such as a latch tip 98 of the test plug / mounting base. including. These anti-rotation components serve to prevent rotation of the mounting base 30 and test plug 130 relative to the connector 20 and ensure that the connector is used only with a compatible test plug and mounting base. Play a role and avoid problems with the compatibility of physical or technical properties. In further embodiments, the width and / or height of the anti-rotation arm may be altered to lock out the aforementioned non-conforming parts. Anti-rotation arms on both sides of the tubular element can prevent rotation and provide additional stability. Each anti-rotation arm prevents rotation about the other anti-rotation arm and rotation about the tubular element. Such an anti-rotation arm may be incorporated into any of the test plugs or mounting bases described herein. Alternatively, in any such configuration, anti-rotation arms 115, 116 may be provided on connector 20, and corresponding recesses 215, 216 may be provided on test plug 130 or mounting base 30.

  From the configuration described with reference to FIGS. 19-22, the present invention also provides a connection configuration for coupling a mounting base portion of a hypodermic sensor or a test plug in place of the mounting base portion to a connector according to a further aspect You can see that it provides. Such a connection is typically necessary to transmit electrical signals from the sensor to an external device such as a blood glucose display or infusion pump, for example when the system is used for diabetes management. . The connection configuration includes a mounting base or a test plug body, which has a mating surface on one side. The connector has a connector interface that forms part of a connection configuration having a mating surface complementary to the mating surface of the body. Projecting from the mating surface of the body is a tubular element 42 having a contact at the end. The connector interface is sized to receive the tubular element 42 and has a socket containing a contact for connecting with a contact at the end of the probe when the connection configuration is engaged. On both sides of the tubular element protruding from the mating surface, there are a pair of anti-rotation posts 115, 116 respectively spaced apart from the tubular element 42. On the complementary surface of the connector interface, there are recesses 215, 216 into which the anti-rotation posts 115, 116 are fitted on both sides of the probe. Typically, if the anti-rotation post engages the wall of the recess, the recess is much wider than the post so that the anti-rotation post engages the wall closest to the tubular element and socket. Further beyond. The body also has a pair of resilient latch arms 97, 98 that protrude from the body at points away from the mating surface and continue to run parallel to the body toward the mating surface. These latch arms then extend beyond the mating surface in the form of an upstanding latch post 98 having an outward chamfered tip. Since the latch arms 97, 98 are resilient, they have a relaxed position in which the latch tip 98 extends and a compression position in which the latch tip moves together, and therefore between the resilient arm and the body. The distance becomes smaller. The recesses 215 and 216 on the complementary surfaces, one on each side of the probe, are sufficiently wide to accommodate the latch posts in addition to the anti-rotation posts 115 and. Each recess has an outer wall on the side in a direction away from the probe, and when the outer wall is in the relaxed position, and the tip is widened, the latch tip fits into the undercut. However, it has a complementary undercut at the latch tip of the latch arm so that it is prevented from retracting by the narrower mouth portion of the slot obstructing the latch post. Therefore, separation of the meshing surface complementary to the meshing surface is prevented. However, when the two latch arms are squeezed together, the two latch arms move to a compressed position where the latch tip escapes from the undercut of the recess and the mating surfaces can be separated. Thus, there are two pairs of posts on either side of the tubular element 42 of the body, and the inner pair serves to avoid rotation. The two pairs stand up from the mating surface directly adjacent to the tubular element, and therefore the rigidity of the body can easily resist any tendency of the tubular element to rotate. The second pair of posts separated from the anti-rotation posts by the air gap is for latching. The second pair of triangular tips are latched in the recesses in the outer wall of the complementary recesses forming the undercut. These latch posts are present at the end of the elastic arm further connected to the mounting base or the back of the test plug body. Typically, these latch posts are made of the same material as the mounting base or test plug, but are relatively thin and resilient. When the arms are squeezed together, the gap between the latch post and the anti-rotation post is reduced, the combination of latches is sufficiently narrow, the narrower mouth escapes by undercut, and escapes from the mouth of the recess on the complementary surface To do. Thus, the latch arm provides elasticity and the anti-rotation post provides stability against rotation, both engage the same pair of recesses in the complementary surface, thus reducing manufacturing costs and overall A simple design.

  FIG. 26 shows a system for connecting a mounting base 30 that has an adhesive layer in the undercut and typically supports the hypodermic sensor to the connector 20. The system may include a transmitter that transmits data from the sensor to the wearing device via a wireless link. The connecting portion between the connector 20 and the mounting base portion 30 may include a connector fitting 36 of the mounting base portion 30 that extends into the connector 20. The mounting base 30 has an upstanding post 261 from which a tubular element 42 extends. The tubular element 42 and the fitting key 50 of the connector fitting 36 can be fitted into the connector 20 to connect the connector 20 to the mounting base portion 30. Once connected, the profile of transition from the mounting base 30 to the connector 20 is smooth.

  When coupled, it is desirable to provide system stability as well as to prevent connection (known as lockout) with non-compliant components. This is achieved in the configuration of FIG. 26 using side rails and slots. The housing of the connector 20 may have a horizontal side rail that engages a horizontal slot on the mounting base 30. More preferably, the upright post 261 of the mounting base 30 may have a horizontal side rail that engages a horizontal slot in the housing of the connector 20. Each slot has an inlet at one end and a lateral end block at the other end. Each side rail has a length less than the distance from the entrance of each slot to the end block. This allows the correct side rail to engage the corresponding slot, but does not engage the side rail and slot longer than the distance from the slot entrance to the end block.

  FIG. 26 shows side rails 260a and 260b on the mounting base 30 that engage slots 262a and 262b in the connector 20. FIG. The side rails 260a and the corresponding slots 262a may have the same or different distances to the side rails 260b and the corresponding slots 262b. FIGS. 27A-27F show various examples of side rail length combinations that could be used to lock out different versions of the mounting base 30 and connector 20. 27A and 27F show, for example, side rails 272 and 273 that differ greatly in length. 27B and 27E show side rails 272 and 273 that do not differ much in length, while FIGS. 27C and 27D show side rails 272 and 273 that have little difference in length. The side rails may also be the same length as each other. The length of the side rail 272 is set to match the distance between the inlet and the end block 270, while the length of the side rail 273 is between the inlet and the end block 271 of the corresponding slot. Therefore, the mounting base portion 30 having one of the rail lengths longer than the distance of the corresponding slot is not engaged with the connector 20.

  Accordingly, the configuration of FIG. 26 typically includes a mounting base 30 typically supporting a subcutaneous sensor, typically containing a transmitter that transmits data from the sensor via a wireless link. The mounting base 30 has an adhesive layer for attachment to the patient on one side and extends from the tubular element 42 parallel to the platform on the other side. Including a platform having a post 261 having a tubular element 42, wherein the connector 20 includes a housing having a socket positioned to engage the tubular element 42 by means of a sliding rail, and a slot engaging with each other. Have. Each slot has an inlet at one end and a lateral end block at the other end, and each side rail has a length less than the distance from the inlet to the end block of the respective slot. As a result, it is possible to lock out the non-conforming type mounting base and the connector. In this case, the at least one side rail is longer than the distance from the entrance of the corresponding slot to the end block. The system of FIG. 26 may incorporate the aforementioned coupling arrangement to provide additional stability as described above.

  In the embodiment shown in FIG. 22, the connector also has catches 217 and 218 that can catch the anti-rotation arm if the anti-rotation arm is hooked, such as a test plug / connector latch tip 98. including. These anti-rotation components serve to prevent rotation of the mounting base / test plug and connector relative to each other, ensuring that the mounting base is only used with a compatible test plug / mounting base. Play a role and avoid problems with the compatibility of physical or technical properties. In further embodiments, the width and / or height of the anti-rotation arm may be changed to lock out the aforementioned non-compliant parts. As shown in FIG. 34, the anti-rotation arms 115, 116 of the mounting base 30 or test plug (not shown) can be at least as wide as height to increase stability and further avoid rotation. It may be preferable. When the anti-rotation arm has at least the same width as the height, there is no possibility that the anti-rotation arm will be easily crushed or broken when pressure is applied, and the possibility of bending will be small. FIG. 35 shows a partial view of the connector 20 having wide rotary arm recesses 215 and 216 that also function as latch recesses for the mounting base / test plug latches. Arrow 1000 is not a part of connector 20 but merely demonstrates rotating arm recesses 215 and 216 that have been widened to allow the wide anti-rotation arm shown in FIG.

  With respect to the anti-rotation arm recess, it is possible to separate and distinguish the anti-rotation arm from the latch recess 100. However, in the figures shown herein, both the latch and anti-rotation arm are for the rotating arm so that the mounting base / test plug latch tip engages the catches 217, 218 (shown in FIG. 22). Since the concave portions 215 and 216 are fitted, the latch concave portion 100 and the latch keeper 102 for engaging the latch front end portion 98 are the same mechanism as the rotary arm concave portions 215 and 216 and the catches 217 and 218.

  In a further embodiment, additional elements are included to provide stability and lock out from non-conforming parts. For example, FIGS. 30 and 31 show a mounting base 30 having lockout columns 117 and 118. As shown in FIGS. 32 and 33 (both figures show partial views of the connector 20), these lockout columns 117 and 118 interact with the lockout pockets 217 and 218 in the connector 20, and these Slide in. A test plug (not shown) may be similarly modified to include a lockout column that can slide into the lockout pockets 217 and 218. When the mounting base / test plug is connected to the connector, the lockout column further prevents rotation between the parts. Furthermore, the lockout column can prevent the mounting base / test plug from being used with a non-compliant connector that does not have a matching lockout pocket (and vice versa). Prevents the use of connectors with non-compliant mounting bases / test plugs). Although two lockout columns are shown in FIG. 30, it is possible to have any reasonable number of lockout columns that correspond to an equal number of lockout pockets on the connector.

  The lockout pocket may be formed by perforating a portion of the connector by injection molding all or a portion of the connector, or by other methods of molding or molding plastic parts known in the art. The lockout column and lockout pocket are fully aligned with the lockout pocket when the test plug or mounting base is connected to the connector when the latch tip 98 is fully engaged with the latch recess 100. It is preferable that it is manufactured so as to be fitted to. In this way, the test plug / mounting base is securely and securely connected to the connector. This tight connection improves water resistance, part stability, and proper connection of electronic components. In further embodiments, material may be added into the pocket to create a more unique shape. This more specific shape can be used to create a better lockout system that uses more specific interlocking components with increased stability or a more specific shape. Cleaning can be facilitated by adding or removing material to change the shape of the pocket. Another advantage of changing the shape of the pocket is to help inform the user which lockout configuration they have, or to allow a set of lockout configurations. One of these configurations is shown in FIG. 33, with added material 2170, 2180 shown in the lockout pocket. The added material may be manufactured from the same material as the other parts of the connector, or a different material suitable for addition to the lockout pockets 217, 218. Polycarbonates and polycarbonate blends (PC / ABS, PC / PBT, etc.) are suitable as additional materials because of their mechanical toughness and ability to be unaffected by common sterilization methods such as electron beam and ETO. However, any thermoplastic resin that is incompatible is considered sufficient as a material.

  In additional embodiments, it is envisioned to provide stability and lockout from non-conforming parts. For example, FIG. 26 shows a mock-up of the mounting base portion and the connector connection portion, where the mounting base portion includes side rails 260 that fit into slots 262 in the connector. FIGS. 27A-27F show various examples of side rail length combinations that could be used to lock out different versions of the mounting base and connectors. As can be seen, the rail length is set to match the slot length so that a mounting base having an incorrect rail length will not fit into the connector. In this configuration, the sensor set forms a substrate on which the connector is placed, so that the same footprint is given to the connector and the substrate, creating a more compact design. The connector slides on a sensor unit that is erected on a board that has a connection within the connector body, which increases the stability in the connected state and reduces the possibility of items being accidentally separated during use. Become. The overall structure has a smooth profile that helps reduce errors, and the sliding engagement has a variety of different length rails (as in FIGS. 27A-27F). This means that the connector needs to be suitable for a particular sensor to properly engage.

  In additional embodiments, the location of the anti-rotation arm extension may vary with respect to the body / central section of the test plug / mounting base. As an example, FIG. 19 shows a top view of a test plug 130 having a body / center section 35. Tubular element 42 extends from the body of the test plug. Extending from this main structure / central section are anti-rotation arms 115 and 116. The latch arm 97 is mounted for further separation from the mounting base or the central section of the test plug, and latching into the latch recess 100 on the connector 20 causes the latch arm 97 to be compressed toward the central section 35. obtain. When the mounting base or test plug is connected to the connector, the latch arm 97 moves toward the central compartment until the latch tip 98 is fully within the latch recess 100 (or recesses 217, 218) and snaps into place. The mounting base / test plug is locked so as not to disconnect in the direction away from the connector until the user wishes to disconnect the component.

  However, in FIG. 36, the central section of the test plug or mounting base (not shown) includes anti-rotation arm extensions 315, 316 between the central section 35 and the anti-rotation arms 115, 116. The anti-rotation arm extending portions 315 and 316 may be inclined downward from the top of the central section 35 toward the anti-rotation arm. By including an anti-rotation arm extension, particularly an anti-rotation arm extension that is inclined downwardly toward the anti-rotation arm, material can be saved when forming a test plug or mounting base. it can. The extension also keeps the pocket clean when the test plug is connected. The extension allows for a more consistent cross-sectional thickness, speeds up molding and reduces surface defects due to material shrinkage.

  Any of the specific features described herein that can be used to lock out non-conforming parts can be used alone or in combination with each other, producing many possible connection configuration iterations. it can. Therefore, it can be ensured that many variations of non-conforming parts cannot be connected to each other.

  The sensor set of the present invention is quickly and easily mounted on the patient's skin in order to place the sensor 12 subcutaneously. In one method of using the sensor of FIG. 4, for example, the mounting base 30 and the connector 20 are coupled together by first engaging a snap-fit latch member. Hub 80 is also installed first. Thereafter, the set is typically pressed against the patient's skin after removing the protective needle guard (not shown) and release film (not shown) from the lower surface of the adhesive patch 34. The pressure sensitive adhesive on the adhesive patch 34 is exposed. When the set is pressed against the skin, the insertion needle 14 pierces the skin, thereby bringing the cannula 58 with the sensor electrode 15 to the desired subcutaneous position. The insertion needle 14 is then slidably disengaged from the cannula and sensor by withdrawing the needle from the patient. If desired, the insertion set 10 may be more firmly secured to the patient by overdressing (not shown). Alternatively, the mounting base may be secured to the patient's skin before connecting to the connector. Therefore, the connector is considered to be connected to the mounting base after the mounting base is comfortably attached to the patient's skin. If the patient wishes to wash or wash the part, the connector can be disconnected. At this point, a dummy socket (not shown) can be connected to the mounting base to protect the electronic components inside the sensor.

  If it is necessary or desirable to remove the sensor from the patient, the insertion set is simply removed from the patient's skin and the sensor is withdrawn from the subcutaneous site. Insertion set 10 can be quickly and easily unassembled from cable connector 20 by properly releasing the snap-fit latch member. The new insertion set 10 can then be assembled with the cable connector and quickly installed on the patient to position the new sensor subcutaneously.

The foregoing description of specific embodiments makes the general essence of this disclosure sufficiently clear, so that when applied to the current knowledge, others can use various applications without departing from the general concept. The system and method can be easily modified and / or adapted to. Accordingly, such adaptations and modifications are within the meaning and scope of the equivalents of the disclosed embodiments. The expressions or terms used herein are for illustrative purposes and are not limiting.

Claims (23)

A connector foil (12) having a contact pad (18) at the end (16);
A connector fitting (36) having a cylindrical element (42) having a key (50) formed at a distal end, wherein the key (50) is defined by a notch in the element (42). A connector fitting (36) defined to produce two flat surfaces each parallel to the axis of the element (42), the flat surfaces facing away from each other; With
The end (16) of the connector foil (12) is located on a first flat surface of the flat surfaces such that the contact pad (18) is opposite the first flat surface. Placed in
A contact portion (96) having a tubular recess (92) sized to receive the element (42) and positioned to engage the contact pad (18) of the connector foil (12) A socket part (20), wherein the socket part (20) comprises a socket part (20) having a structure that occupies a space emptied by the cutout part.   The connector foil (12) wraps around the end of the key (50) so that it lies on both of the flat surfaces, and the contact pad (18) is positioned opposite the flat surface. The connector system according to claim 1.   The structure that occupies the space emptied by the cutout portion includes a spring contact on one side of the key (50) and a protrusion inside the tubular recess (92) on the other side of the key (50). The connector system according to claim 1, comprising:   The connector system of claim 1, wherein the first flat surface is located on a diameter of the cylindrical element (42).   The end of the key (50) has a predetermined profile, and the inner end of the tubular recess (92) has a complementary interengagement profile. The described connector system.   The connector foil (12) includes a test circuit for testing a device connected to the socket part (20) when the plug part (130) and the socket part (20) are engaged. The connector system as described in any one of -5. A sensor set for detecting a characteristic of a patient, the sensor set comprising the connector system according to claim 1,
The connector foil (12) includes a medical sensor having the contact pad (18) at a proximal end (16) and a sensing structure at a distal end (15) and an intermediate compartment (24);
The cylindrical element (42) is formed as part of a mounting base (30) that is operable for mounting on the patient's skin, for pass-through reception of the intermediate section (24) of the medical sensor. A sensor set having a central hole (44).   The sensor set according to claim 7, further comprising a test plug including the connector system according to claim 6. A sensor set for detecting characteristics of a patient, the sensor set comprising:
A sensor (12) having a distal segment (15) at a distal end for generating at least one electrical signal representative of patient characteristics, said sensor (12) being at a proximal end (16) Including at least two contact pads (18), each of the at least two contact pads (18) coupled to the distal segment (15) to receive the electrical signal from the distal segment (15) A sensor (12),
A mounting base portion (30) operable for mounting on a patient's skin, wherein the mounting base portion (30) is a connector fitting (36) at a substantially rear end portion of the mounting base portion (30). The connector fitting (36) includes a cylindrical element (48) having a central hole (44) formed therein for receiving a pass-through portion of the sensor (12). Part (30);
A connector (20) operable to couple to the mounting base (30), wherein the connector (20) is sized to receive the connector fitting (36) of the mounting base. When the determined tubular recess (92) and the mounting base (30) are connected to the connector (20), they are electrically connected to the at least two contact pads (18) of the sensor. A connector (20) comprising at least two connector contacts (96) that are operable;
The connector fitting (36) includes a key (50) formed at one end, and the proximal end (16) of the sensor (12) is at least one of the at least two contact pads, Of the key (50) such that it is on a first side of the key (50) and at least one other of the at least two contact pads is on a second side of the key (50). A sensor set that can be folded around.   The sensor set according to claim 9, wherein the at least two connector contact portions of the connector are compression-type pins.   The sensor of claim 10, wherein the compression pin is compressed into the first side of the key and the second side of the key when the mounting base is coupled to the connector. set.   The sensor set according to claim 9 or 10, wherein the sensor includes a short-circuit path serving as a short-circuited reference electrode and a counter electrode.   The sensor set according to any one of claims 9 to 12, wherein the sensor includes a resistor.   The sensor set according to any one of claims 9 to 13, wherein the key includes at least one protrusion adapted to fit into a protrusion recess formed in the mounting base portion.   15. A sensor set according to any one of claims 9 to 14, wherein the first side of the key is substantially flat.   16. A sensor set according to claim 15, wherein the second side of the key includes a substantially flat end portion and a shelf portion.   17. The first side of the key and the second side of the key each include a seat for receiving the proximal end of the sensor. Sensor set.   The mounting base includes at least one arm generally adjacent to the cylindrical element of the connector fitting, the at least one arm being within the connector when the connector is connected to the mounting base. 18. The sensor set according to any one of claims 9 to 17, wherein the sensor set is formed so as to be fitted in at least one corresponding arm recess formed in.   The connector fitting includes a first side rail formed on a first side of the connector fitting, and a second side rail formed on a second side of the side rail, When the connector is connected to the mounting base portion, the first side rail and the second side rail are connected to the first slot formed in the tubular recess of the mounting base portion and the tubular recess of the connector. 19. A sensor set according to any one of claims 9 to 18, operable to slide into a formed second slot.   20. The sensor set according to any one of claims 9 to 19, wherein the connector includes a wireless transmitter that is operable to transmit a signal from the mounting base.   The sensor set according to any one of claims 9 to 20, wherein the characteristic is blood glucose.   The at least two sensor electrodes are operable to generate at least two electrical signals representative of the characteristic, and the at least two connector contacts are operable to receive the at least two electrical signals. The sensor set according to any one of claims 9 to 21. 23. The mounting base portion and the connector each have a releasable interlocking snap-fit latch member operable to lock the mounting base portion to the connector. Sensor set according to

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